MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CDX18093530
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial mdr report being submitted for this complaint with associated mfr# 2954740-2017-00136.Additional procode: krd.(b)(4).Concomitant medical product: microcatheter (coiling support, hi-lex corporation) the product will not be returned for analysis however a device history record.Review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a health care professional, during the procedure a deltamaxx cerecyte 18sys (cdx18093530/c34622) coil failed to detach.The procedure was the endovascular aneurysm repair of an aneurysm at the internal iliac artery.Coils (presidio18x12mm, deltamaxx 10mm, deltamaxx 9mm) were inserted in order, after which the deltamaxx (complaint product ) was inserted as the fourth coil and the coil was placed.However, the coil could not be detached.Therefore, the coil was replaced with another one (different lot #, same size).The procedure was successfully completed without further issues or delay.There was also no patient injury or complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The product is not available for investigation.No further information is available.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00136.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.There is no current safety signal identified related to the reported event based on review of complaint history for the device.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6643243
• Report Number: 2954740-2017-00136
• Device Sequence Number: 11089181
• Product Code: HCG
• UDI-Device Identifier: 10878528008603
• UDI-Public: (01)10878528008603(17)200331(10)C34622
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: CDX18093530
• Device Lot Number: C34622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 07/28/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 06/21/2017; 06/22/2017; 07/31/2017
• Patient Sequence Number: 1